Daré Bioscience(US:DARE)2025-11-13 21:03Financial Performance - Total revenue for the three months ended September 30, 2025, was $2,262, a decrease of 94.6% compared to $41,691 for the same period in 2024[19] - Loss from operations for the three months ended September 30, 2025, was $3,672,148, compared to a loss of $4,681,349 for the same period in 2024[19] - Net loss for the nine months ended September 30, 2025, was $11,957,556, compared to a net income of $1,452,799 for the same period in 2024[19] - Total revenue for the nine months ended September 30, 2025, was $6,517, down from $73,431 in 2024, indicating a decrease of about 91.1%[144] - The company reported a comprehensive loss of $3,555,906 for the three months ended September 30, 2025, compared to a loss of $4,679,566 for the same period in 2024[19] Operating Expenses - Operating expenses for the three months ended September 30, 2025, were $3,674,410, down 22.2% from $4,723,040 in the prior year[19] - Segment operating expenses for the three months ended September 30, 2025, were $3,674,410, compared to $4,723,040 in 2024, a reduction of approximately 22.2%[144] - Research and development direct program costs for the three months ended September 30, 2025, totaled $641,668, down from $1,539,276 in 2024, a decrease of approximately 58.3%[144] - Personnel-related costs, including stock-based compensation, for the three months ended September 30, 2025, were $1,168,085, compared to $1,429,180 in 2024, a decline of about 18.2%[144] Cash and Assets - Cash and cash equivalents increased to $23,075,261 as of September 30, 2025, from $15,698,174 as of December 31, 2024, representing a growth of 47.1%[18] - Total assets as of September 30, 2025, were $30,748,574, an increase of 39.5% from $22,101,131 as of December 31, 2024[18] - The company had unrestricted cash and cash equivalents of approximately $23.1 million and working capital of approximately $3.8 million as of September 30, 2025[37] - Cash equivalents increased from approximately $15.3 million as of December 31, 2024, to approximately $22.7 million as of September 30, 2025[48] Liabilities and Equity - Total liabilities decreased slightly to $27,890,671 as of September 30, 2025, from $28,113,220 as of December 31, 2024[18] - The company had a total stockholders' equity of $2,857,903 as of September 30, 2025, compared to a deficit of $(6,012,089) as of December 31, 2024[18] - The company’s accumulated deficit increased to $(187,247,186) as of September 30, 2025, from $(169,783,232) as of September 30, 2024[25] - The company’s total stockholders' equity as of September 30, 2025, was $2,857,903, compared to a deficit of $(1,484,483) as of September 30, 2024[25] Cash Flow - The company reported net cash used in operating activities of $(11,330,134) for the nine months ended September 30, 2025, compared to net cash provided of $167,637 for the same period in 2024[28] - The Company reported negative cash flow from operations of approximately $11.3 million for the nine months ended September 30, 2025[39] Funding and Grants - The Company has received a total of $12.8 million in non-refundable payments from Organon, recorded as license fee revenue[52] - The Company is entitled to receive up to $180.0 million in tiered commercial sales and regulatory milestones from Organon[53] - The Company received a $1.0 million grant from NIAID for DARE-HPV development, with an additional $1.0 million recommended for the subsequent project year[128] - The Company was awarded approximately $2.0 million from NICHD to support the development of DARE-PTB1, with recorded expenses of approximately $0.2 million and $0.5 million for the three and nine months ended September 30, 2025, respectively[129] Stock and Financing - The Company has the right to sell up to $15.0 million of shares of its common stock to Lincoln Park Capital Fund, LLC over a 24-month period starting November 27, 2024[87] - During the nine months ended September 30, 2025, the Company sold 900,000 shares of common stock under the Lincoln Park agreement for net proceeds of approximately $2.0 million[89] - The Company sold 4,329,116 shares of common stock under the ATM sales agreement for aggregate gross proceeds of approximately $18.0 million, resulting in net proceeds of approximately $17.6 million after expenses[90] Development and Licensing Agreements - The company announced a dual-path approach to market new products, pursuing both traditional FDA approval and earlier market access via Section 503B outsourcing facilities[32] - The company entered into a co-development and licensing agreement with Theramex for a biodegradable contraceptive implant, Casea S, receiving a royalty-free, exclusive license in exchange for 50% of the purchase price paid by Theramex[64] - Under the Douglas License Agreement, the company may make future payments of up to $5.25 million for development milestones and up to $64.0 million for commercial sales milestones, with no payments made as of September 30, 2025[66] - The Hennepin License Agreement allows for potential payments of up to $6.25 million for development milestones and up to $45.0 million for commercial sales milestones, with no payments made as of September 30, 2025[68] Concerns and Future Outlook - There is substantial doubt about the Company's ability to continue as a going concern within the next 12 months[39] - The Company updated its forecast of Net Royalty Payments, resulting in an estimated Financing Term extending through 2037, with an effective interest rate of 12.8%[114]